25 Sept. 2003 Frankfurt, Germany1 U.S. FDA Approach to Auditing Including QSIT Christine Nelson...

25 Sept. 2003 Frankfurt, Germany 1

U.S. FDA Approach to Auditing Including QSIT

Christine Nelson

Center for Devices & Radiological Health

Food & Drug Administration


FDA-Speak Terms

Inspection = Audit

Investigator = Auditor


Why does FDA inspect device manufacturers?

To evaluate compliance with the following FDA device regulations: Quality Systems Medical Device Reporting Medical Device Tracking Reports of Corrections and

Removals Registration and Listing


Who conducts inspections for FDA?

1. FDA investigators in 20 FDA District Offices around the U.S.

2. FDA-trained Auditors from Conformity Assessment Bodies in the European Union (EU)

3. In the future, FDA-trained auditors from independent third parties accredited by FDA


How does FDA decide who to inspect?

Registration database identifies who manufactures devices for distribution in the U.S.

Listing database identifies what devices they distribute

FDA prioritizes inspections by risk and gives higher risk devices/situations a higher priority


What is high priority for inspection?

Device manufacturers that: Make class III devices

Make implantable devices and life supporting and life sustaining devices

Recently introduced a new device to the market

Have had significant violations in the past


Does FDA notify the manufacturer of an upcoming inspection?

FDA calls domestic manufacturers about 5 days before the inspection

FDA contacts foreign manufacturers 2 - 3 months in advance to schedule inspection

Manufacturer is requested to send Quality System Manual or equivalent for pre-inspection review


What happens when the FDA investigator arrives at the site?The FDA investigator will:

Ask to see the top management

Present credentials (identifies person as an FDA investigator)

Issue notice of inspection explaining FDA’s legal authority to inspect (only in the U.S.)


What happens during the inspection? Investigator may tour the facility to get

an idea of layout, workflow, and areas

that may need closer inspection

This helps the investigator

decide how to organize

the inspection


What happens next?

The investigator will: Ask about size and structure of

company, who is in charge, what products are manufactured there

Review registration and listingEvaluate compliance with FDA

regulations using the Quality System Inspection Technique (QSIT)


What is QSIT?

GGUIDEUIDE TOTO I INSPECTIONSNSPECTIONS OFOF QQUALITYUALITY S SYSTEMSYSTEMS

FOOD AND DRUG ADMINISTRATION

August 1999August 1999

www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm


What is QSIT?

Identifies 4 major subsystems to evaluate and states the purpose and importance of each subsystem

Provides flowcharts and inspectional objectives to cover during inspection

Offers advice Provides tables for statistical sampling

of records for review


What are the four main subsystems?

Design Controls

MaterialControls Records,

Documents, &Change Controls

Equipment & Facility Controls

Production & Process Controls

Corrective &Preventive

Actions

Management


What does FDA look for in the Management Subsystem?Quality Policy established?

Management representative appointed?

Management reviews conducted?


What does FDA look for in the Management Subsystem?Quality audit procedures

established and quality audits conducted?

Quality plan established?

Quality system procedures established?


What does FDA look for in the Design Control Subsystem? Design procedures and plan established?

Design inputs or requirements for device identified?

Design outputs or specifications for device identified?

Design verification conducted?

Design validation conducted?


What does FDA look for in the Design Control Subsystem?Software validation completed?

Risk analysis carried out?

Design reviews conducted?

Design transfer to manufacturing completed successfully?


What does FDA look for in the Corrective and Preventive Action Subsystem?

CAPA procedures established?

Sources of data analyzed to identify nonconforming product and quality problems?

Statistical analysis across data sources?

Investigations conducted to identify root cause of failures?


What does FDA look for in the Corrective and Preventive Action Subsystem?

Nonconforming product controlled?

Appropriate corrective actions and preventive actions carried out?

Those responsible are told about CAPA activities?

Management review of CAPA activities?


What does FDA look for in the Production and Process Control Subsystem?

Processes are controlled and monitored?

Any rejects or nonconforming product?

Equipment adjusted, calibrated and maintained?


What does FDA look for in the Production and Process Control Subsystem?

Manufacturing processes validated or fully verified?

Software validated?

Production employees trained and qualified?


What about the other subsystems?

The other three subsystems are covered through links with the four main subsystems:

Records, documents and change control

Facility and equipment control

Material control


What happens at the end of the inspection? The investigator will:

Meet with management to discuss the inspection

Present the FDA 483 list of observations of any significant deficiencies

Discuss the deficiencies


What should the manufacturer do after the inspection? Send a letter to FDA identifying how they

have corrected deficiencies or will correct them

Provide documentation of any corrections that have been completed

Provide a timetable or estimated completion date for future corrections


Where should I send the letter?

Office of Compliance

Center for Devices and Radiological Health (CDRH)

Food and Drug Administration

2094 Gaither Road, HFZ-300

Rockville, Maryland 20850

U.S.A.


Center for Devices & Radiological HealthOffice of the

Center Director

Office of Device Evaluation

Office of In Vitro DiagnosticDevice Evaluation & Safety


Office of Surveillance& Biometrics

Office of Science& Technology

Office of Systems& Management

Office of Health &Industry Programs

Division of Small Manufacturers,International & Consumer Assistance



Division of Enforcement A

Dental, ENT & Ophthalmic Devices

OB/GYN, Gastro & Urology Devices

General Hospital Devices

General Surgery Devices

Division of Enforcement B

Cardiovascular & Neurological Devices

Diagnostic X-ray Devices

Electronic Products & Devices

Orthopedic, Physical Medicine & Anesthesiology Devices


What happens next?

Investigator writes an “Establishment Inspection Report” or EIR

EIR is sent to the Office of Compliance, Center for Devices and Radiological Health (CDRH)

Inspection is classified based on inspectional findings

Office of Compliance reviewer writes Warning Letter for inspection classified “OAI”


How does FDA classify inspection reports? NAI – No action indicated

VAI – Voluntary action indicated – some deficiencies identified but not serious

OAI – Official action indicated – serious deficiencies identified, and FDA must take action to assure correction


What actions can FDA take to address OAI inspections?

For device manufacturers outside the U.S.:

Warning Letter

Warning Letter + Automatic Detention


Warning Letter

FDA sends “Warning Letter” describing manufacturer’s violations of FDA regulations and requesting a reply within 15 days


Warning Letter + Automatic Detention

FDA sends “Warning Letter” describing manufacturer’s violations of FDA regulations and requesting a reply within 15 days

Manufacturer’s products are put on automatic detention to prevent them from entering the U.S.


What will the Warning Letter say about Automatic Detention? Given the serious nature of these violations of

the Act, all products manufactured at this facility may be detained without physical examination upon entry into the United States. In order to prevent your devices from being detained without physical exam, your firm will need to respond to this Warning Letter (as set forth below) and correct the violations noted in this letter. In addition, the agency usually needs to conduct a follow-up inspection to verify that the appropriate corrections have been implemented.


How do I get my devices off automatic detention?

Submit documentation to FDA showing that deficiencies have been corrected

FDA will inspect you to confirm that corrections are adequate before lifting automatic detention


Where can I get more information about FDA inspections and regulations?

QSIT:

http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF

http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm

Inspections of Medical Device Manufacturers Compliance Program 7382.845: http://www.fda.gov/ora/cpgm/default.htm#devices More . . .



Quality system regulation: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

General quality system info: http://www.fda.gov/cdrh/devadvice/32.html

Investigations Operations Manual: http://www.fda.gov/ora/inspect_ref/iom/default.htm

More . . .



Other medical device regulations: http://www.fda.gov/cdrh/devadvice/

Division of Small Manufacturers, International and Consumer Assistance - E-mail: [email protected]

Christine Nelson – E-mail: [email protected]


Summary

Quality System Inspection Technique (QSIT)

How FDA conducts inspections

What should a manufacturer do after an inspection

Warning Letter or Warning Letter + Automatic Detention

Where to go for more information

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